ELF TINTED MOISTURIZER by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

ELF TINTED MOISTURIZER by

Drug Labeling and Warnings

ELF TINTED MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF TINTED MOISTURIZER SPF-20- octinoxate, oxybenzone, and titanium dioxide cream 
J. A. Cosmetics U.S. INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient:

OXINOXATE: 6%

OXYBENZONE: 3.5%

TITANIUM DIOXIDE: 5%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

• Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or skin aging.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

When Using This Product

• KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Stop use and ask a doctor if

• rash occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

• Apply generously 15 minutes before sun exposure.
• Apply to clean skin in an upward and outward motion with Makeup Sponge or Foundation Brush.
• Children under 6 months of age; ask a doctor.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

Other Information

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

Inactive Ingredient:

WATER (AQUA), PARAFFINUM LIQUIDUM (MINERAL OIL), PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STEARETH-21, DIMETHICONE, STEARETH-2, CETEARYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, XANTHAN GUM, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, RETINYL PALMITATE (VA), TOCOPHERYL ACETATE (VE), MAGNESIUM ASCORBYL PHOSPHATE (VC), ALOE VERA LEAF JUICE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499)

ELF TINTED MOISTURIZER  SPF-20
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.5   in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-2 (UNII: V56DFE46J5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-102-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-102-11	25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/10/2013	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 3/2014

Document Id: 05595f04-c411-44a2-8e24-9da53c107373

34390-5

Set id: 6f39a1ea-b43e-455f-b742-a2cd9822d4ce

Version: 3

Effective Time: 20140319

 

J. A. Cosmetics U.S. INC